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Tegretol

Tegretol
Tegretol is used for some epilepsy attacks control. It is also used for the treatment of heavy pain at chews and checks, caused by face nerve problems (trigeminus neuralgia). It can be used for other goals defined by your doctor.

Brand: Carbamazepine

Availability: In Stock
Average Delivery Time: 9 Days
Exp. Date: May 2024
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Tegretol 400 mg
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Tegretol 200 mg
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Tegretol 100 mg
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Product description

Drug title

Tegretol (Carbamazepine)

Pharmacological action

Antiepileptic drug. Tegretol is a dibenzodiazepine derivative. Along with antiepileptic, the drug also has neurotropic and psychotropic effects.


As an antiepileptic agent, Tegretol is effective in focal (partial) epileptic seizures (simple and complex), accompanied or not accompanied by secondary generalization, in generalized tonic-clonic epileptic seizures, as well as in combinations of these types of seizures.


In clinical studies, when using Tegretol as monotherapy in patients with epilepsy (especially in children and adolescents), a psychotropic effect of the drug was noted, which was manifested, in particular, by a positive effect on the symptoms of anxiety and depression, and by a decrease in irritability and aggressiveness. According to a number of studies, the effect of Tegretol on cognitive function and psychomotor performance depended on the dose and was either questionable or negative. Other studies noted a positive effect of the drug on the indicators characterizing attention, learning and memory ability.


As a neurotropic agent, Tegretol is effective for a number of neurological diseases, for example, it prevents pain attacks in idiopathic and secondary trigeminal neuralgia. In addition, Tegretol is used to relieve neurogenic pain in various conditions, including dry spinal cord, post-traumatic paresthesias and post-herpetic neuralgia. In alcohol withdrawal syndrome, Tegretol increases the threshold of seizure readiness (which is reduced in this condition) and reduces the severity of clinical manifestations of the syndrome, such as agitation, tremor, gait disturbances. In patients with non-sugar diabetes of central genesis Tegretol reduces diuresis and the feeling of thirst.


As a psychotropic agent, Tegretol is effective for affective disorders, namely for treatment of acute manic states, for maintenance treatment of bipolar affective (manic-depressive) disorders (both as monotherapy, and in combination with neuroleptic agents, antidepressants or lithium preparations), in schizoaffective psychosis, manic psychosis, where it is used in combination with neuroleptics, and in acute polymorphic schizophrenia (rapid cycling episodes).


The mechanism of action is associated with blockade of potential-dependent sodium channels, which leads to stabilization of membranes of overexcited neurons, inhibition of neuronal serial discharges and reduction of synaptic impulse conduction. The anticonvulsant effect is mainly due to stabilization of neuronal membranes and reduction of glutamate release, reduction of the activity of the excitatory neurotransmitter amino acid glutamate, since glutamate is the main mediator, there is no publication about the role of aspartate. Increases the reduced CNS seizure threshold and thus reduces the risk of an epileptic seizure. Increased potassium conductance and modulation of calcium channels activated by high membrane potential may also contribute to the anticonvulsant effect of the drug. It eliminates epileptic personality changes and eventually increases patients' sociability and promotes their social rehabilitation. Can be prescribed as the main therapeutic agent and in combination with other anticonvulsants.

Pharmacokinetics

Absorption


After oral administration, carbamazepine is absorbed almost completely, although relatively slowly. After a single dose of a normal tablet, Cmax is reached after 12 hours. There are no clinically significant differences in the degree of absorption of the active substance after using different oral dosage forms of the drug. After a single oral administration of a tablet containing 400 mg of carbamazepine, the average Cmax value of unchanged active substance is about 4.5 µg/ml.


After oral administration (single or repeated) of retard tablets Cmax is reached within 24 hours, its value is 25% lower than that of conventional tablet. When taking retard tablets daily fluctuations in plasma concentration of carbamazepine are less pronounced, while there is no significant decrease in the minimum Css value. When taking the drug in the form of retard tablets 2 times/day, the fluctuations in plasma concentrations of the active substance are very small. The bioavailability of the active substance from the retard tablets is about 15% lower than that of other dosage forms of the drug.


Food intake does not significantly affect the rate and degree of absorption of carbamazepine, whichever dosage form of Tegretol is used.


The plasma Css of carbamazepine are reached within 1-2 weeks, which depends on the individual characteristics of metabolism (autoinduction of liver enzyme systems by carbamazepine, heteroinduction by other, simultaneously used drugs), as well as on the patient's condition, the drug dose and duration of treatment. Significant interindividual differences in Css values in the therapeutic range are observed: in most patients, these values range from 4 to 12 mcg/mL (17-50 μmol/L). Concentrations of carbamazepine-10,11-epoxide (pharmacologically active metabolite) are about 30% of carbamazepine concentrations.


Distribution


The binding of carbamazepine to plasma proteins is 70-80%. The concentration of unchanged carbamazepine in cerebrospinal fluid and saliva is proportional to the proportion of the active substance not bound to proteins (20-30%). The concentration of carbamazepine in breast milk is 25-60% of its level in plasma.


Carbamazepine penetrates the placental barrier. If absorption of carbamazepine is considered complete, the apparent Vd is 0.8-1.9 L/kg.


Metabolism


Carbamazepine is metabolized in the liver, predominantly via the epoxide pathway, resulting in the major metabolites, the 10,11-transdiol derivative and its conjugate with glucuronic acid. The main isoenzyme responsible for the biotransformation of carbamazepine to carbamazepine-10,11-epoxide is CYP3A4. These metabolic reactions also produce the inactive metabolite 9-hydroxy-methyl-10-carbamoylacridan.


Excretion


After a single oral intake of this medicine, T1/2 of unchanged carbamazepine is on average about 36 hours, and after repeated intakes of this medicine - on average 16-24 hours (due to auto-induction of hepatic monooxygenase system), depending on the duration of treatment. In patients concomitantly taking other drugs inducing the same liver enzyme system (e.g. phenytoin, phenobarbital), T1/2 of carbamazepine has an average duration of 9-10 hours.


After a single oral dose of 400 mg carbamazepine, 72% of the taken dose is excreted in the urine and 28% in the feces. About 2% of the administered dose is excreted with urine as unchanged carbamazepine, about 1% - as pharmacologically active 10,11-epoxide metabolite, and about 30% - as final metabolites formed as a result of epoxide metabolism.


Pharmacokinetics in special clinical cases


In children, due to the more rapid elimination of carbamazepine, higher doses of the drug per kg body weight may be required compared to adults.


There are no data indicating that the pharmacokinetics of carbamazepine are altered in elderly patients (compared to young adults).


No data on the pharmacokinetics of carbamazepine in patients with impaired renal or hepatic function are available to date.

Contraindications to use

  • AV-blockade;
  • History of episodes of suppression of medullary hematopoiesis or evidence of acute intermittent porphyria;
  • combination with MAO inhibitors (structural similarity with tricyclic antidepressants). MAO inhibitors should be withdrawn at least 2 weeks before prescribing Tegretol or, if the clinical situation allows, even longer;
  • Hypersensitivity to carbamazepine or chemically similar drugs (e.g. tricyclic antidepressants) or to other drug components.

Use during pregnancy and lactation

Treatment with Tegretol for epilepsy in pregnancy should be used with extreme caution.


In women of childbearing age, Tegretol should, if possible, be used as monotherapy, because the rate of congenital fetal abnormalities born to women treated with a combination of antiepileptic drugs is higher than in those who received each of these drugs as monotherapy.


The lowest effective dose of Tegretol should be administered. Regular monitoring of plasma carbamazepine levels is recommended.


If a woman receiving Tegretol becomes pregnant or if Tegretol is to be prescribed during pregnancy, the expected benefits of therapy and the possible complications should be carefully compared, especially in the first trimester of pregnancy.


Children born to mothers with epilepsy are known to be more prone to intrauterine disorders, including malformations. It has been reported that carbamazepine, like all major antiepileptic drugs, may increase the risk of these disorders, although definitive confirmation of this from controlled studies using Tegretol as monotherapy is not available to date. There are, however, isolated reports of cases of congenital diseases and malformations, including spina bifida and other congenital anomalies (including craniofacial and cardiovascular) that have been observed in patients treated with Tegretol. Patients should be given information about the possibility of increased risk of malformations and the opportunity to undergo antenatal diagnosis.


Folic acid deficiency is known to develop during pregnancy. Antiepileptic drugs have been reported to exacerbate this deficiency. This may contribute to an increased incidence of birth defects in children born to women taking antiepileptic drugs. Therefore, additional folic acid supplementation is recommended before and during pregnancy.


In order to prevent increased bleeding in newborns, it is recommended to administer vitamin K1 to women in the last weeks of pregnancy, as well as to newborns.


Carbamazepine is excreted with breast milk, with concentrations of 25-60% of plasma levels. Therefore, the benefits and possible adverse effects of breastfeeding in the setting of continued therapy with Tegretol should be compared. Mothers taking Tegretol may continue breastfeeding, but provided that the child is monitored for the development of possible side effects (e.g., marked somnolence, allergic skin reactions).


Use in liver dysfunction

Before Tegretol administration and during treatment, liver function should be investigated, especially in patients with a history of liver disease and in elderly patients. In case of an aggravation of pre-existing liver dysfunction or in the appearance of active liver disease, Tegretol should be immediately discontinued.

Use in impaired renal function

In patients with a history of renal impairment, the drug should be administered only after careful analysis of the ratio of the expected effect of treatment to the possible risk of therapy and while ensuring careful and regular monitoring.

Administration in children

In children aged 4 years and younger, it is recommended to start treatment with 20-60 mg/day and increase the dose by 20-60 mg every other day.


In children over 4 years of age, treatment may be initiated with a dose of 100 mg/day; the dose is increased gradually by 100 mg weekly.

Use in elderly patients

The recommended starting dose for elderly patients is 100 mg twice daily.

Indications of Tegretol

  • Epilepsy: complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalization; generalized tonic-clonic epileptic seizures; mixed forms of seizures (Tegretol can be used both as monotherapy and in combination therapy; Tegretol is usually ineffective in small seizures /petit mal, absans/ and myoclonic seizures)
  • acute manic states and maintenance therapy for bipolar affective disorder to prevent exacerbations or to lessen clinical manifestations of exacerbations;
  • alcohol withdrawal syndrome;
  • idiopathic trigeminal neuralgia and trigeminal neuralgia in multiple sclerosis (typical and atypical); idiopathic pharyngeal neuralgia;
  • diabetic neuropathy with pain syndrome;
  • Non-sugar diabetes of central genesis; polyuria and polydipsia of neurohormonal nature.


Dosing regimen

The drug may be taken during or after meals or between meals, together with a small amount of liquid.


Retard tablets (a whole tablet or half, if so prescribed by the doctor) should be swallowed whole, without chewing, with a small amount of liquid. Since the active ingredient is released from the retard tablets slowly and gradually, they are prescribed 2 times a day.


Transfer of a patient from taking regular tablets to receiving retard tablets: clinical experience shows that in some patients when using retard tablets it may be necessary to increase the dose of the drug.


Taking into account drug interactions and different pharmacokinetics of antiepileptic drugs, doses of Tegretol should be chosen with caution in elderly patients.


In epilepsy, whenever possible, Tegretol should be prescribed as monotherapy.


Treatment begins with a small daily dose, which is then slowly increased until the optimal effect is achieved.


To select the optimal dose of the drug, determination of plasma levels of the active ingredient is recommended.


When Tegretol is added to existing antiepileptic therapy, this should be done gradually, and the doses used are not changed or, if necessary, corrected.


For adults, the initial dose of Tegretol is 100-200 mg once or twice daily. Then the dose is slowly increased until optimal therapeutic effect is achieved; it is usually achieved at a dose of 400 mg/day, administered in 2-3 doses. Some patients may require a dose of Tegretol of 1.6 g/day or 2 g/day.


In children 4 years of age and younger, it is recommended that treatment begin with 20-60 mg/day and increase the dose by 20-60 mg every other day.


In children over 4 years of age, treatment may be initiated with a dose of 100 mg/day; the dose is increased gradually by 100 mg each week.


In trigeminal neuralgia the initial dose of Tegretol is 200-400 mg/day. It is slowly increased until pain sensations disappear (usually to a dose of 200 mg 3-4 times/day), and then gradually reduced to the minimum maintenance dose. The recommended starting dose for elderly patients is 100 mg twice daily.


In alcohol withdrawal syndrome, the average dose is 200 mg 3 times/day. In severe cases, in the first few days, the dose may be increased (e.g., to a dose of 400 mg 3 times/day). In severe manifestations of alcohol withdrawal, treatment is started with a combination of Tegretol and sedative-hypnotics (e.g., clomethiazole, chlordiazepoxide). After resolution of the acute phase, treatment with Tegretol may be continued as monotherapy.


In non-sensory diabetes of central genesis, the average dose for adults is 200 mg 2-3 times per day. In children, the drug dose should be reduced according to the age and body weight of the child.


In diabetic neuropathy with pain syndrome, the average dose of Tegretol is 200 mg 2-4 times/day.


In acute manic states and maintenance treatment of affective (bipolar) disorders the daily dose is 400-1600 mg. The average daily dose is 400-600 mg (in 2-3 doses). In acute manic states, the dose of Tegretol should be increased rather quickly. In case of maintenance therapy of bipolar disorders, in order to ensure optimal tolerability, a gradual increase of the dose by a small amount is recommended.